Summary This is an individual contributor/support position that will act as a part of a larger DPS embedded client-based team providing Process Manufacturing and Engineering design support. The Process Engineer will contribute to the creation of design and technical documents to support our DPS client scope and objectives. Common work products will include generation of PFDs, P&IDs, Process Lists, Equipment Specifications and Commissioning start up protocols for new process equipment. In this position, the Process Engineer will work closely with vendors to ensure technical deliverables are achieved for the scope of the assigned project. The Process Engineer must have a strong desire to learn new technical platforms and process technologies as they apply to the relevant life sciences Clients that DPS support.
Key Responsibilities - Develop, Review Approve technical content of P&IDs, and complete back-check process ensuring drawing accuracy based on defined scope and deliverables.
- Develop block flow and process flow diagrams based on client direction
- Leverage appropriate Client standards, generate project specific Process Specifications.
- Generate vendor bid packages from equipment specifications and complete technical bid analysis based on vendor quotations.
- Evaluate and Define process equipment utility requirements from vendor data and complete utility system capacity studies based on this and site data.
- Review and perform basic process calculations including pump sizing, hydraulic/pipe flow, and heat transfer.
- Complete engineering field surveys and P&ID walkdowns, document findings and ensure resolution where issues are found.
- Attend relevant design and client-based meetings to drive Project scope and deliverables.
- Lead process related deviations and provide technical support to manufacturing
- Investigate, identify root cause for critical deviations and determine CAPA for manufacturing
- Write product impact assessments to support deviations
- Write and review technical documentation (batch records, SOPs, protocols & reports)
- Participate and report to a cross-functional development team to advance production activities
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process development studies to develop a thorough understanding of operating and process performance parameters
- Perform hands-on activities that support process engineering from drafting procedures to execution of commissioning start up studies.
- Other duties as assigned
Skills & Qualifications - Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with at least 2 plus years of GMP Lifesciences, pharmaceutical manufacturing, technology transfer & process development experience required.
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Mastery of scientific and engineering Principles
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal, and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills
